Fighting for Women’s Health: Innovation in Breast Cancer treatment

In 2020, cases of breast cancer breached 2 million,¹ making it the most frequently diagnosed cancer in women worldwide. The increase in cases was attributed to lifestyle changes and better screening tools. Survival in the present day still heavily depends on staging and the molecular subtype. Molecular subtypes have provided breakthrough insights into new treatment strategies over the years and management have continued to evolve as more about the disease is understood.

During the Philippine Society of Medical Oncology (PSMO) 36th annual convention, women’s health was once again highlighted in the lecture “Reimagine the Future of Breast Cancer.” Dr Josephine Tolentino, Dr See Hui Ti, Dr Ellie May Villegas and Ms Aileen Antolin shared their insights during the session which was moderated by Dr Pamela Padtu.

Dr Tolentino provided updates from the 2022 Department of Health (DOH) breast cancer clinical practice guidelines and the treatment algorithm for human epidermal growth factor 2 (HER2)- positive early breast cancer. According to studies, neoadjuvant therapy has several benefits: 1) it enables early response assessment resulting in improved long-term outcomes, 2) enhances surgical options, 3) gives way to the downstaging of breast tumors, 4) allows chances of conservative surgery, 5) decreases surgical morbidity, and 6) permits early systemic treatment.²-⁶

International guidelines recommend the use of neoadjuvant therapy in patients with high-risk disease at diagnosis, (tumor of more than 2cm or node-positive). Per the National Comprehensive Cancer Network Breast Cancer Guidelines 2022, German Gynaecological Oncology Group Guidelines 2020, European Society for Medical Oncology Guidelines 2019, St. Gallen Guidelines 2019, and the 2022 Breast Cancer National Clinical Practice Guidelines, pertuzumab plus trastuzumab is the recommended neoadjuvant treatment for patients with high- risk HER2-positive early breast cancer.⁷-¹¹

In the APHINITY trial, subjects with confirmed HER-2 status were assigned randomly to either chemotherapy with trastuzumab and pertuzumab or chemotherapy with trastuzumab and placebo and were monitored for 10 years. Pertuzumab significantly improved the rates of invasive- disease-free survival among patients with HER2-positive, operable breast cancer when it was added to trastuzumab and chemotherapy. No new cardiac safety issues were also noted during the interim analysis.¹²

After neoadjuvant therapy, patients are assessed if they are more suitable for a conservative type of surgery than a total breast and axillary surgery based on the treatment response. Once surgery is done, adjuvant therapy options is assessed. Those who have received neoadjuvant therapy should be assessed on their response to the prior therapy and have two adjuvant therapy options: to either complete 18 cycles for patients with pathological complete response or 14 cycles of ado-trastuzumab emtansine for patients with residual invasive disease as done in the KATHERINE trial. Those with low-risk HER2-positive early breast cancer may potentially avail of radiotherapy rather than adjuvant chemotherapy.⁷-¹¹

Dr See Hui Ti joined virtually via zoom from Singapore and gave a readout of the FeDerica and PHranceSCa clinical trials. The FeDerica trial is a registrational trial for fixed-dose subcutaneous formulation of trastuzumab and pertuzumab. The randomized trial was done on patients who were newly diagnosed with early-stage HER2-positive breast cancer and were candidates for neoadjuvant therapy with chemotherapy. Patients were divided into two groups, one received standard chemotherapy with intravenous (IV) trastuzumab and pertuzumab versus the subcutaneous formulation of trastuzumab and pertuzumab. Both arms had favorable endpoints, and there was no significant statistical difference in the trough levels of both methods.

The PHranceSCa trial likewise enrolled early-stage HER2-positive breast cancer patients however this was now done as adjuvant therapy and subjects were randomized to either IV or subcutaneous trastuzumab plus pertuzumab. Each group underwent three cycles of their assigned treatment and crossover to the other treatment. The subjects were then asked which of the two formulations they preferred. Results from the trial revealed that 85% of patients preferred or strongly preferred the subcutaneous formulation and 90% chose the subcutaneous formulation as their regimen moving forward. Factors influencing the patients’ decisions included time saved, comfort, and ease of administration.¹⁴-¹ ⁵

Dr Pamela Padtu was joined by Dr Josephine Tolentino, Dr See Hui Ti, Dr Ellie May Villegas, and Ms Aileen Antolin in a panel discussion where the experts highlighted how the subcutaneous formulation of trastuzumab plus pertuzumab is a welcomed breakthrough during the time of the pandemic and at present.

Dr Pamela Padtu was joined by Dr Josephine Tolentino, Dr See Hui Ti, Dr Ellie May Villegas, and Ms Aileen Antolin in a panel discussion where the experts highlighted how the subcutaneous formulation of trastuzumab plus pertuzumab is a welcomed breakthrough during the time of the pandemic and at present.

Dr See Hui Ti described how it allowed patients to be in and out of the doctor’s clinic in less than an hour, thus decreasing the risk of exposure. Dr Villegas reiterated the convenience of this formulation as it allows working women to go about their daily lives without making a dent in their daily schedules.

Preparation for this new formulation required less manpower and was less taxing to healthcare workers compared with the IV formulation. On the health protocols implemented during the pandemic, the doctors reflected on how hard and heartbreaking it was to have to stop chemotherapy sessions during lockdowns. They emphasized that treatment wouldn’t have been missed if subcutaneous trastuzumab plus pertuzumab was available in the country during those times.

Ms Aileen Antolin, the Trustee for Program Development of the Philippine Foundation for Breast Care (Kasuso Foundation) thanked the doctors for their hard work in fighting for women’s health and wished for a continued partnership to advocate for breast cancer awareness in the coming years. She noted that despite the existing barriers preventing women from accessing adequate healthcare in the country, the foundation will continue to work hard in promoting women’s health and breast cancer awareness the best it can.



The session was then closed by Dr Diana Edralin, General Manager of Roche and President of the Pharmaceutical and Healthcare Association of the Philippines. She talked about feeling empowered to be able to share the innovation brought about by pertuzumab + trastuzumab (Phesgo®), which will give women with breast cancer a better quality of life and enable them to live fuller lives. She also talked about being thankful to be working hand-in-hand with advocates from the public and private sectors in identifying and addressing the unique needs of women with cancer to provide holistic and tailored women-centered cancer care.

During the COVID-19 crisis, Roche - in partnership with PSMO, patients, patient groups and hospitals - extended exemplary efforts to help cancer patients receive the care they need. Roche aims to continue to come up with innovative ways and establish more dynamic partnerships with a shared goal of advancing women’s health in the country, as women have the unique role of being the world’s caregivers, therefore they deserve the utmost care possible.

References: 1.      Arnold M, Morgan E, Rumgay H, Mafra A, Singh D, Laversanne M, et al. Current and future burden of breast cancer: global statistics for 2020 and 2040 Breast, Published online 2 September 2022. 2.      Cain H, Macpherson IR, Beresford M, Pinder SE, Pong J, & Dixon M.. Neoadjuvant Therapy in Early Breast Cancer: Treatment Considerations and Common Debates in Practice. Clinical oncology (Royal College of Radiologists (Great Britain)), 29(10), 642–652, 2017. 3.      Swain, San & Macharia, Harrison & Cortes, Javier & Dang, Chau & Gianni, Luca & Hurvitz, Sara & Jackisch, Christian & Schneeweiss, Andreas & Slamon, Dennis & Valagussa, Pinuccia & Toit, Yolande & Heinzmann, Dominik & Knott, Adam & Song, Chunyan & Cortazar, Patricia. Abstract P1-18-01: Risk of recurrence and death in patients with early HER2-positive breast cancer who achieve a pathological complete response (pCR) after different types of HER2- targeted therapy: A retrospective exploratory analysis. Cancer Research. 80. P1-18. 10.1158/1538-7445.SABCS19-P1-18-01, 2020. 4.      Loibl, Sibylle & Untch, Michael & Buyse, Marc & Robidoux, André & Gianni, Luca & Schneeweiss, Andreas & Conte, Pierfranco & Piccart, Martine & Bonnefoi, Hervé & Jackisch, Christian & Nekljudova, Valentina & Costantino, Joseph & Valagussa, Pinuccia & Neate, Colin & Gelber, Richard & Poncet, Coralie & Squifflet, Pierre & Saad, Everardo & Heinzmann, Dominik & Cortazar, Patricia. Abstract P5-06-02: Pathologic complete response (pCR) and prognosis following neoadjuvant chemotherapy plus anti-HER2 therapy of HER2-positive early breast cancer (EBC). Cancer Research. 80. P5-06. 10.1158/1538-7445.SABCS19-P5-06-02, 2020. 5.      Volders, JH, Negenborn VL, Spronk PE, Krekel NMA, Schoonmade LJ, Meijer S, Rubio IT, & van den Tol MP. Breast-conserving surgery following neoadjuvant therapy-a systematic review on surgical outcomes. Breast cancer research and treatment, 168(1), 1–12, 2018. 6.      Pernaut C, Lopez F, & Ciruelos E. Standard Neoadjuvant Treatment in Early/Locally Advanced Breast Cancer. Breast care (Basel, Switzerland), 13(4), 244–249, 2018. 7.      NCCN Breast Cancer Guidelines. Version 4, 2022. 8.      AGO Breast Cancer Guidelines. Version 1, 2020. 9.      Cardoso F, Kyriakides S, Ohno S, Penault-Llorca F, Poortmans P, Rubio IT, Zackrisson S, Senkus E, & ESMO Guidelines Committee. Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology: Official Journal of the European Society for Medical Oncology, 30(8), 1194–1220, 2019. 10.   Burstein HJ, Curigliano G, Loibl S, Dubsky P, Gnant M, Poortmans P, Colleoni M, Denkert C, Piccart-Gebhart M, Regan M, Senn HJ, Winer EP, Thurlimann, B, & Members of the St. Gallen International Consensus Panel on the Primary Therapy of Early Breast Cancer 2019Estimating the benefits of therapy for early-stage breast cancer: the St. Gallen International Consensus Guidelines for the primary therapy of early breast cancer 2019. Annals of Oncology: Official Journal of the European Society for Medical Oncology, 30(10), 1541–1557,2019. 11.   Trastuzumab (Herceptin®) Full Prescribing Information. Roche (Philippines) Inc. 2019. Data on File. 12.   Loibl S, Jassem J, Sonnenblick A, et al: Updated results of APHINITY at 8.4 years median follow-up. ESMO Virtual Plenary. Abstract VP6-2022l, 2022 13.   Von Minckwitz et al. European Society for Medical Oncology. Published by Elsevier Ltd. 2022.06.009, 2022. 14.   Bartsch R, Minichsdorfer C, & Kolberg-Liedtke C. Results from the FeDeriCa trial: Are we reducing the burden of breast cancer treatment? The Lancet Oncology, 22(1), 5–6, 2021. 15.   O'Shaughnessy J et al. PHranceSCa study group. Preference for the fixed-dose combination of Pertuzumab and Trastuzumab for subcutaneous injection in patients with HER2-positive early breast cancer (PHranceSCa): A randomised, open-label phase II study. Eur J Cancer. 2021 Jul;152:223-232, 2021.

Pharmacovigilance Pregnancy Statement For HCPs: If a patient becomes pregnant while receiving Pertuzumab + Trastuzumab fixed-dose combination for subcutaneous administration (Phesgo®) or within 7 months following the last dose of Pertuzumab + Trastuzumab (Phesgo®), please immediately report the pregnancy to the Roche Philippines Local Safety Unit via philippines.drug_safety@roche.com. Additional information will be requested during a Pertuzumab + Trastuzumab (Phesgo®) -exposed pregnancy and the first year of the infant’s life. This will enable Roche to better understand the safety of Pertuzumab + Trastuzumab (Phesgo®) and to provide appropriate information to health authorities, healthcare providers and patients. For additional information, please refer to the Pertuzumab + Trastuzumab (Phesgo®) Product Information.Please review product information before prescribing. Full prescribing information available at https://medinfo.roche.com/en/prescribing-information- finder.html or email philippines.medinfo@roche.com. For medical information queries and product quality complaints, please email: philippines.medinfo@roche.com For suspected adverse drug reaction, please report to the Food and Drug Administration (FDA) at www.fda.gov.ph and to the Roche (Philippines) Inc. Local Safety Unit at philippines.drug_safety@roche.com. At the first sign of any drug reaction, the patient should seek medical attention immediately.

Date of Production: May 2023 © 2022 Roche (Philippines) Inc. All rights reserved. PM-PH-00001162